Safety Study of Treatment of Leg Fractures
Stopped early
Conditions studied: Tibial Fractures
In brief
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.
Key facts
- Study ID
- NCT03881241
- Run by
- Smith & Nephew, Inc.
- People needed
- 2
- Starts
- 2019-09-20
- Expected to finish
- 2020-03-24
- Last updated by the study team
- 2020-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subject who is 18 years of age or older at the time of signing the informed consent.
- Subject provides an Institutional Review Board (IRB)-approved informed consent. The subject must have the physical and mental capacity to provide informed consent for him/herself.
- Subject has experienced proximal tibial fracture (OTA Type 41 A-C) or distal tibial fracture (OTA 43 Type A-C) with or without fibular/malleolar involvement (OTA 44 A-C) and are scheduled for ORIF using the EVOS SMALL Plating System.
- Subject is willing and able to attend all study visits including 1 year post-operative follow-up.
You may not qualify if…
- Subject has contraindications or hypersensitivity to the use of the EVOS SMALL Plating System or its components (316L stainless steel).
- Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or retard healing, such as blood supply impairment, insufficient bone quality or quantity, previous infection, obesity, severe bow or gross bony distortion of the tibia, as detailed in the IFU.
- Subject has, in the opinion of the Investigator, an emotional or neurologic condition that precludes cooperation and compliance with the rehabilitation regimen.
- Subject is currently in another investigational drug, biologic, or device study or has been treated with an investigational product within the last 30 days.
- Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
Where it is running
- Athens Orthopedic Clinic — Athens, Georgia, United States
- John Peter Smith Hospital — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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